Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

September 23, 2011 updated by: Wol Seon Jung, Gachon University Gil Medical Center
  • Gynecological surgery is associated with a high incidence of postoperative nausea and vomiting.
  • NK1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited.
  • We performed a prospective, randomized, double-blinded placebo-controlled study of 123 female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125 mg aprepitant, or a placebo.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

123 female patients (ages 21-60) undergoing laparoscopic hysterectomy

  1. 80mg aprepitant
  2. 125mg aprepitant
  3. placebo

Incidences of nausea, vomiting/retching, and use of rescue antiemetics were recorded at 0, 1, 2, 24, and 48 h after surgery.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Inchon, Korea, Republic of, 405-760
        • Gil Medical Center Gachon University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use

Exclusion Criteria:

  • liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: aprepitant 125mg
NK1 receptor antagonist
Aprepitant 80 mg, Aprepitant 125 mg
Active Comparator: Aprepitant 80 mg
Aprepitant 80 mg, Aprepitant 125 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The numbers (and percentages) of patients who experienced complete response
Time Frame: 48 hours postoperatively
  • The numbers (and percentages) of patients who experienced complete response, i.e. no nausea, retching, vomiting, or need for rescue treatment
  • required rescue therapy and peak nausea scores
  • Adverse effects in the three treatment groups
48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: WOL SEON JUNG, M.D. Ph.D., Gil Medical Center Gachon University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (Estimate)

September 26, 2011

Study Record Updates

Last Update Posted (Estimate)

September 26, 2011

Last Update Submitted That Met QC Criteria

September 23, 2011

Last Verified

September 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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